Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block

NCT ID: NCT02536430

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-31

Brief Summary

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Detailed Description

Objectives:

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.

Design: Randomized double blind clinical trial

Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration

Main outcome measures : Pain during caries and dentin removal , access cavity preparation and canals length measurements using VAS.

Conditions

Failed Mechanical Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Buccal infiltration of Ketorolac

A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.

Group Type: ACTIVE_COMPARATOR

Ketorolac Tromethamine

Intervention Type: DRUG

One group received a buccal infiltration of Ketorolac Tromethamine

buccal infiltration of Normal Saline

A buccal infiltration of Normal Saline was applied for the patients in control group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

buccal infiltration of Normal Saline.

Interventions

Ketorolac Tromethamine

One group received a buccal infiltration of Ketorolac Tromethamine

Intervention Type: DRUG

Placebo

buccal infiltration of Normal Saline.

Intervention Type: DRUG

Other Intervention Names

Toradol; Normal Saline

Eligibility Criteria

Inclusion Criteria

• patients with age ranged 18-65;
• without systemic diseases;
• without any medicine consumption;
• non smoking;
• non pregnant;
• non breast feeding;
• with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular molar that needs root canal treatment

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nahid Mohammadzadeh Akhlaghi

OTHER

Sponsor Role: lead

Responsible Party

Nahid Mohammadzadeh Akhlaghi

Doctor Nahid Mohammadzadeh Akhlaghi

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nahid Mohammadzadeh Akhlaghi, DDS,MDS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Dental Branch, AZad UMS

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

AZadUMS-P/212/D

Identifier Type: -

Identifier Source: org_study_id